| Primary Device ID | B013DRUJIS045 |
| NIH Device Record Key | e68c24cd-8476-421b-9d73-cb666b18c3ff |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DRUJ-IS045 |
| Catalog Number | DRUJ-IS045 |
| Company DUNS | 780455338 |
| Company Name | APTIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B013DRUJIS045 [Primary] |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
[B013DRUJIS045]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-06-05 |
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| B013DRUJLDG250 - Scheker Prosthesis | 2023-06-09 Locking Drill Guide 2.5mm |
| B013DRUJKW540 - Scheker DRUJ | 2021-12-06 K-Wire D. TROCAR 4" 1.4 MM [.054'"] |
| B013DRUJKWD0 - Scheker DRUJ | 2021-12-06 K-Wire Dispenser 6 3/4" |
| B013MITDRUJ1000 - Scheker DRUJ | 2021-12-06 Metal Instrument Tray, Distal Radioulnar Joint |
| B013MITINT1000 - Scheker DRUJ | 2021-12-06 Metal Instrument Tray, Interchangeable |
| B013DRUJB10200 - NA | 2021-09-06 Distal Radioulnar Joint Ball Size 10 or Size 20 |
| B013DRUJB200 - NA | 2021-09-06 UHMWP Ball, 9.5 mm, Size 20 |